This trial is completed!
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
2Find
3Review
4Get in touch
More info
You can access this
clinical trial
if you have
EV71-associated Disease
and you are
between 21 and 51
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
Show me locations

The purpose

Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community. The phase II study of inactivated vaccine (vero cell) against EV71 has completed last month in Jiangsu Province in China. The data from the phase II study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. But the antibody titer against EV71 was found decreased significantly at month 8 compared to that at day 56. Considering the similar dynamic trend had also been found in the antibody against poliovirus induced by polio vaccines, and whose immunization schedule contains a booster dose administrated at 1 to 1.5 year after the first 3 doses of fundamental immunity. In order to find a better immunization schedule for children, the investigators decided to perform this booster immunity trial among these children who had received two doses of EV71 vaccines (around one year after the fundamental immunity). The investigators do the recruitment among these children who had participated in the previous phase II trial and received EV71 vaccines, and randomize them in a ratio of 2:1 to receive either a booster dose of EV71 vaccines or placebo.

Provided treatments

  • Biological: alum-adjuvant 160U /0.5ml
  • Biological: alum-adjuvant 320U /0.5ml
  • Biological: alum-adjuvant 640U /0.5ml
  • Biological: adjuvant-free 640U /0.5ml
  • Biological: 0/0.5ml placebo
Tris trial is registered with FDA with number: NCT01734408. The sponsor of the trial is Jiangsu Province Centers for Disease Control and Prevention and it is looking for 773 volunteers for the current phase.
Official trial title:
A Booster Dose of Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children